Cisplatin and fluorouracil alone or with docetaxel in head and neck cancer

Marshall R. Posner, Diane M. Hershock, Cesar R. Blajman, Elizabeth Mickiewicz, Eric Winquist, Vera Gorbounova, Sergei Tjulandin, Dong M. Shin, Kevin Cullen, Thomas J. Ervin, Barbara A. Murphy, Luis E. Raez, Roger B. Cohen, Monica Spaulding, Roy B. Tishler, Berta Roth, Rosana Del Carmen Viroglio, Varagur Venkatesan, Ilya Romanov, Sanjiv AgarwalaK. William Harter, Matthew Dugan, Anthony Cmelak, Arnold M. Markoe, Paul W. Read, Lynn Steinbrenner, A. Dimitrios Colevas, Charles M. Norris, Robert I. Haddad

Research output: Contribution to journalArticlepeer-review

1189 Scopus citations

Abstract

BACKGROUND: A randomized phase 3 trial of the treatment of squamous-cell carcinoma of the head and neck compared induction chemotherapy with docetaxel plus cisplatin and fluorouracil (TPF) with cisplatin and fluorouracil (PF), followed by chemoradiotherapy. METHODS: We randomly assigned 501 patients (all of whom had stage III or IV disease with no distant metastases and tumors considered to be unresectable or were candidates for organ preservation) to receive either TPF or PF induction chemotherapy, followed by chemoradiotherapy with weekly carboplatin therapy and radiotherapy for 5 days per week. The primary end point was overall survival. RESULTS: With a minimum of 2 years of follow-up (≥3 years for 69% of patients), significantly more patients survived in the TPF group than in the PF group (hazard ratio for death, 0.70; P = 0.006). Estimates of overall survival at 3 years were 62% in the TPF group and 48% in the PF group; the median overall survival was 71 months and 30 months, respectively (P = 0.006). There was better locoregional control in the TPF group than in the PF group (P = 0.04), but the incidence of distant metastases in the two groups did not differ significantly (P = 0.14). Rates of neutropenia and febrile neutropenia were higher in the TPF group; chemotherapy was more frequently delayed because of hematologic adverse events in the PF group. CONCLUSIONS: Patients with squamous-cell carcinoma of the head and neck who received docetaxel plus cisplatin and fluorouracil induction chemotherapy plus chemoradiotherapy had a significantly longer survival than did patients who received cisplatin and fluorouracil induction chemotherapy plus chemoradiotherapy. (ClinicalTrials.gov number, NCT00273546.)

Original languageEnglish (US)
Pages (from-to)1705-1715
Number of pages11
JournalNew England Journal of Medicine
Volume357
Issue number17
DOIs
StatePublished - Oct 25 2007

ASJC Scopus subject areas

  • Medicine(all)

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